Efforts Ongoing to Move Biosimilars Into Mainstream Cancer Care

Lee S. Schwartzberg, MD

OneOncology is seeking to streamline the ease of delivering oncologic care and considers the commercial availability of biosimilars as an integral component in these efforts, explained newly appointed chief medical officer of the company, Lee S. Schwartzberg, MD.

For example, on August 8, 2019, the company announced that it would make 2 Amgen biosimilars—the bevacizumab (Avastin) biosimilar bevacizumab-awwb (Mvasi) and the trastuzumab (Herceptin) biosimilar trastuzumab-anns (Kanjinti)—preferred products at its partner practices.

“When the therapeutic [biosimilars] were being developed, we did a very careful analysis of the clinical data and the process by which these drugs were approved, and felt that they would offer patients in the OneOncology practices the advantage of a lower cost option with the same clinical outcome,” explained Schwartzberg. “We believe biosimilars will offer a lower-cost option to all the stakeholders in the cancer system, including patients, practices, and payers.”

In an interview with OncLive, Schwartzberg, who is also the executive director of West Cancer Center, chief of the Division of Hematology/Oncology at the University of Tennessee Health Science Center, and chair of the Association of Community Cancers Center Immuno-Oncology Institute Executive Committee, discussed the mission of OneOncology as well as the work that is being done to bring biosimilars to the market.

OncLive: Could you discuss the new oncology model of OneOncology, its mission, and what you hope to achieve in this role?

Schwartzberg: The mission of OneOncology is to improve the lives of patients with cancer by organizing community oncology practices to deliver the best possible cancer care. We're doing that by being physician-led, investing in practices, and working with the management of OneOncology to improve the efficiencies of care. All of this is being done through the standardization of technology and the office, as well as working together with the practices to develop clinical initiatives that will benefit each of them.

The standardization includes a common electronic medical record (EMR) platform so that the data can be aggregated. OneOncology is also investing in a data analytic platform called OneAnalytics, which will provide practices with key performance, financial, and operational indicators. We're working on providing clinical metrics as well. We expect that the practices will use these metrics to improve processes and clinical care as well as patient experience.

From a clinical perspective, we're working on pathways. We will be developing OneOncology wide pathways, which we hope to integrate into the EMR with our technology partner Flatiron Health as a clinical decision support tool. This will reduce variations in the way that regimens and supportive care are delivered. We're expanding to include other parts of the cancer ecosystem beyond medical oncology, including radiation oncology. We have a large number of radiation oncologists in the OneOncology network, as well as surgeons, gynecologic oncologists, and radiologists, among others to serve as a real “one-stop shop” for patients with cancer.

Additional initiatives we are working on include the development of a research network, as well as a comprehensive precision oncology system, where all appropriate patients are molecularly profiled so that they can receive the best care. We have been paying particular attention to quality as we see value-based arrangements emerging. We're already participating in the [Oncology Care Model], and we’re hoping to shape the next generation of value-based contracting.

OneOncology has announced that its partner practices have already begun administering 2 Amgen biosimilars. Could you discuss the decision to purchase the biosimilars?

We've been following the biosimilar story for quite some time now. We've seen their adoption in Europe, as they are about a decade ahead of us. The first biosimilars were supportive care drugs, an area I am very familiar with as it has been a focus of my research career.We previously conducted an in-depth evaluation of the process by which biosimilars were approved, as well as the clinical data of which their approvals were based on. I felt very comfortable with the first wave of biosimilars in the supportive care space. Clinically, I felt that these drugs were able to deliver the same results as the originator products.

What does this say about your commitment to these products?

The FDA very carefully approaches the approval of biosimilars on the basis of showing highly similar analytic processes. The evaluation of how the originator product compares with [a biosimilar] is a very rigorous and multidimensional process. The FDA has ensured the safety [of these products] by looking very carefully and longitudinally at the presence or absence of developing antibodies—particularly neutralizing antibodies—to see whether there is a difference between these products and the originator products. Clinical trial data can also be extrapolated in some cases. If you look at the bulk of the evidence for the trastuzumab or the bevacizumab biosimilars, you see that they've been tested in multiple settings and they’ve met the equivalency criteria.

Therefore, we're very comfortable that a biosimilar is an appropriate choice with benefits. Even originator biosimilars have slight differences from one another because of the complex process used to generate these drugs. [Biologics] are very different from small molecules. The rigorous attention placed on these analytics by the FDA ensures that the new products meet the standards [put in place for originator biologics].

Could you discuss your overall stance on the use of biosimilars? How have these products revolutionized the field?

We believe all new patients would be comfortable using biosimilars in either the palliative or the curative setting, particularly as it relates to trastuzumab, which is used in both settings within the HER2-positive breast cancer space. We believe that's a very reasonable strategy. Before any patient is switched over to a biosimilar, we explain the potential behind such a switch, and then obtain informed consent. The decision of whether or not they want to switch is up to the patient. If a patient will continue an originator drug for a short and specified period of time, such as the adjuvant setting, we typically [would not switch that patient] because it generates additional work on everyone’s part. For [newly diagnosed] patients or those who may be on treatment long-term, we’ll offer them a biosimilar in the indication in which it’s approved with informed consent.

What research with biosimilars are you currently working on?

We've done some retrospective reviews and we have several planned that are focused on patient experience with biosimilars. Ultimately, we'd like to look at outcomes, but, of course, that's a long-term goal. First and foremost, we have to determine that adverse events are no different for biosimilars than one would expect from the originator product. In other words, [we’re looking at] real-world evidence to support the clinical trial data that have been generated.

What data have read out over this last year with biosimilars that you’re excited about?

We've seen very good data with the trastuzumab biosimilars, of which there are now 5. These products have been investigated in various settings, including the neoadjuvant, adjuvant, and metastatic settings. We've started to see longer-term data on some of these biosimilars. We saw 3-year data on 1 of the trastuzumab biosimilars that continue to show, even after neoadjuvant therapy, that disease-free survival is maintained. Pathologic complete response was used as a surrogate endpoint in some of the trials. We're seeing long-term evidence that there was no accumulation of neutralizing antibodies over longer periods of use. Data that have been accruing from Europe with the use of these agents include real-world evidence showing that these agents are safe and effective.

Could you speak to the hesitance in the community to use biosimilars? What can be done to make their use more widespread?

The reticence is due to the fact that biosimilars are very new products, and their developmental process differs from that of standard therapeutic drugs. It's sort of an inverted pyramid where most of the work is done at the analytic level and much less at the clinical level, which is necessary if biosimilars are going to come in with a cost differential. [Cost] is one of the major driving forces for biosimilars. When the cost of developing the drug is less, that can be passed on as a reduction in the cost to the patient and the payer. It's a different process; it's still new in the United States.

There's also still confusion about what a biosimilar is; the definition itself is somewhat awkward. It’s a highly similar product, but it's hard to find a different synonym. It's a concept that people are still coming to grips with. As they come out more broadly in the oncology world and as they start to be used more often, the comfort level will go up. It’s just like anything else. Some people may want to take their time before they jump in, but OneOncology believes the time is now.